Thai FDA’s Proposed Draft Notification: Annual Sa…
Thai FDA proposes a draft Notification mandating annual safety reports for terminated or completed clinical research, aligning with Herbal P…
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Pharma and Biotech
FDA Guidance on Developing Chimeric Antigen Receptor (C…
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products. Focused on s…
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Pharma and Biotech
US FDA Eases Informed Consent for Minimal Risk Clinical…
FDA Implements 21st Century Cures Act: Effective 30 days post-publication, ensuring rights and safety of human subjects. The final rule amen…
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Pharma and Biotech
FDA Proposes Human Abuse Potential Study for Kratom
FDA allocates $2 million for institutions conducting a Human Abuse Potential (HAP) study on botanical Kratom due to rising concerns over its…
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Pharma and Biotech
Thailand Imposes Ban on Sale of Kratom Leaves: MoPH Ann…
On December 25, 2023, Thailand’s MoPH published the announcements on the prohibition on selling kratom leaves, or food containing krat…
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Food and Nutrition
Australia: TGA Repeals Advertising Permission for Nicot…
The Therapeutic Goods Administration (TGA) has repealed the Advertising Permission for Nicotine, effective from 1 January 2024. This move co…
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Pharma and Biotech
Increased Risk of Neurodevelopmental Disorders in Child…
New research indicates a higher risk of neurodevelopmental disorders in children when fathers took valproate three months before conception.…
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Pharma and Biotech
California AB 82: Regulations on Sale of OTC Weight Los…
California Assembly Bill 82, addresses the sale of weight loss supplements to minors, introducing essential regulations. Initially introduce…
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Food and Nutrition
Canada Announces Public Consultation on Plastic Polluti…
The Government of Canada, via Environment and Climate Change Canada, opens a 45-day public comment period until February 13, 2024, for propo…
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ESG
ANVISA adopts new flows to request for consent to impor…
ANVISA (Brazil) Introduces Streamlined Processes for Importing Experimental Medicines: New procedures exclude pre-boarding inspections for d…
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Pharma and Biotech